Cervicogenic HeadachePhase 1PTRHBCOP-CGHNCT07271004
Proprioceptive Training Reduces Headache Burden and Center of Pressure Path Length in Patients With Cervicogenic Headache
A Phase 1 study testing Proprioception and Conventional physical therapy in people with Cervicogenic Headache, run by Hungarian University of Sports Science at 1 site in Egypt.
Trial summary
Cervicogenic headache (CGH) is a secondary headache originating from dysfunction in the cervical spine and is associated with impaired sensorimotor control and postural instability. Read more about this study
- Who is it for?
- Ages 35 to 49 years
- Conditions the study is for
- Cervicogenic Headache
- What is being tested?
- Proprioception and Conventional physical therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteEgypt
- Study dates
- 3 Jul 2024to 20 Sep 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 49 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Physician-diagnosed cervicogenic headache (CGH) according to current diagnostic criteria
- Age 35 to 49 years
- Unilateral pain originating in the neck and radiating to the frontotemporal region
- Pain aggravated by neck movements
- Restricted cervical range of motion
- Joint tenderness in at least one upper cervical joint (C1-C3)
- Headache frequency of at least one episode per month for the past year
Who cannot join
- History of head or neck injury or surgery
- Musculoskeletal disorders
- Neurological diseases or disorders
- Metabolic syndromes
- Hypertension or hypotension
- Vestibular disorders
- Inner ear inflammation
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Faculty of physical therapy kfs university
Kafr ash Shaykh, Kafr el-Sheikh Governorate, 33511
About this study
Official title: Proprioceptive Training Reduces Headache Burden and Center of Pressure Path Length in Patients With Cervicogenic Headache: A Randomized Controlled Trial
Cervicogenic headache (CGH) is a secondary headache originating from dysfunction in the cervical spine and is associated with impaired sensorimotor control and postural instability. This randomized, assessor-blinded, parallel-group clinical trial aims to investigate whether adding gaze direction recognition (GDR)-based proprioceptive training to a conventional physiotherapy program can reduce headache burden and improve postural balance in individuals with CGH. Participants are randomly allocated to receive either standard physiotherapy or standard physiotherapy plus GDR training for eight weeks. Primary outcomes include headache frequency, headache duration, and center-of-pressure (COP) path length during quiet standing. The study is conducted in accordance with ethical guidelines and was approved by the relevant institutional review board.
Read the detailed description
Cervicogenic headache (CGH) is a secondary headache arising from disorders of the cervical spine and related structures. Individuals with CGH commonly present with impaired cervical proprioception and altered postural control. Sensorimotor retraining strategies, such as gaze direction recognition (GDR), have been used in chronic neck pain populations to target proprioceptive deficits; however, their application in CGH has not been comprehensively investigated.
This randomized, controlled, assessor-blinded clinical trial is designed to evaluate whether adding proprioceptive GDR training to a standardized physiotherapy program results in greater reductions in headache burden and improvements in postural balance compared with physiotherapy alone. Thirty-eight participants meeting ICHD-3 diagnostic criteria for CGH are randomly assigned in a 1:1 ratio to a control group receiving standard physiotherapy or to a treatment group receiving standard physiotherapy plus GDR training. The intervention is delivered three times per week for eight weeks.
The standardized physiotherapy program includes thermotherapy, transcutaneous electrical nerve stimulation (TENS), ultrasound therapy, and therapeutic exercises for cervical mobility, posture correction, and isometric strengthening. The treatment group receives the same program with the addition of a structured GDR proprioceptive task.
Gaze Direction Recognition Exercise (GDRE) Procedure:
During the GDRE, the therapist sits in a chair positioned 0.75 m behind the center of a wooden table (1.8 × 0.4 × 0.76 m). Six wooden blocks, numbered 1 to 6 from left to right, are placed along the table edge nearest the therapist, spaced 0.31 m apart. Patients sit in a chair behind the therapist with a clear view of the numbered blocks.
An assistant signals the start of each trial, at which point the therapist randomly directs his gaze and head toward one of the blocks. As patients observe the therapist's neck rotation from behind, they rotate their own head in the same direction and verbally report the number of the block they believe the therapist is looking at. Patients are instructed to avoid moving other body parts during head rotation. No accuracy feedback is provided to the patient. The assistant records both reaction time and accuracy for each response. Each GDRE session consists of 30 trials and lasts approximately 10 minutes.
Primary outcomes include headache frequency (attacks per month), headache duration (hours per attack), and center-of-pressure (COP) path length during quiet standing, measured at baseline and after eight weeks of intervention. The study protocol was reviewed and approved by the Faculty of Physical Therapy Ethics Committee, Cairo University, and all participants provide written informed consent before enrollment.
- Conditions
- Cervicogenic Headache
- Being tested
- Proprioception, Conventional physical therapy
- Keywords
- Cervicogenic Headache;, Headache Burden, Postural Balance, Proprioception, Eye Movements
- Medical subject headings
- Post-Traumatic Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProprioceptionOther
The GDR training involved observing another person's head and neck rotations from behind and identifying the direction of gaze, requiring motor imagery and visuospatial judgment to activate cervical sensorimotor pathways. Task difficulty was progressively increased across sessions.
Training was administered three times per week for eight weeks, each session lasting approximately 60 minutes.
Would you like me to now write the Intervention Description sections (the short entries that go under "Intervention Name," "Type," and "Description" linked to each arm)? Those are the next fields after the Arm descriptions.
Conventional physical therapyOther
20 minutes of moist heat applied to the neck and shoulder region,
20 minutes of transcutaneous electrical nerve stimulation (TENS) at 50 Hz and 100 µs pulse width,
5 minutes of continuous-mode ultrasound therapy (1-1.5 W/cm²) to the cervical muscles, and
A series of therapeutic exercises to improve cervical mobility, posture correction, and neck-muscle strength through isometric contractions.
| Study group | Role | What they receive |
|---|---|---|
| Proprioceptive | Experimental | Participants in the experimental group received the same standard physiotherapy program as the control group, with the addition of a 10-minute proprioceptive Gaze Direction Recognition (GDR) training task during each session.
The GDR training involved observing another person's head and neck rotations from behind and identifying the direction of gaze, requiring motor imagery and visuospatial judgment to activate cervical sensorimotor pathways. Task difficulty was progressively increased across sessions.
Training was administered three times per week for eight weeks, each session lasting approximately 60 minutes. Receives: Other: Proprioception |
| Control Group | Active comparator | Participants in the control group received a standardized physiotherapy program three times per week for eight weeks. Each 60-minute session included:
20 minutes of moist heat applied to the neck and shoulder region,
20 minutes of transcutaneous electrical nerve stimulation (TENS) at 50 Hz and 100 µs pulse width,
5 minutes of continuous-mode ultrasound therapy (1-1.5 W/cm²) to the cervical muscles, and
A series of therapeutic exercises to improve cervical mobility, posture correction, and neck-muscle strength through isometric contractions.
This program represented the conventional physiotherapy regimen for cervicogenic headache management. Receives: Other: Conventional physical therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Headache frequency (attacks per month)
Change in the number of cervicogenic headache attacks per month, as recorded by participants in a headache diary. Headache frequency was averaged over four weeks at baseline and again at post-intervention. Lower values indicate improvement.
Measured: Baseline and after 8 weeks of intervention
Headache duration (hours per attack)
Change in the mean duration of headache episodes, expressed in hours per attack, recorded from participant headache diaries. Duration was averaged across all episodes within each 4-week period at baseline and post-treatment.
Measured: Baseline and after 8 weeks of intervention
Secondary outcomes (1)
Center of Pressure (COP) path length (cm)
Change in total center-of-pressure path length measured during quiet standing using the HUMAC Balance System (CSMi, USA). Shorter path length reflects improved postural stability and sensorimotor control.
Measured: Baseline and after 8 weeks of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2025
- Study start3 Jul 2024
- Primary completion15 Aug 2025
- Study completion20 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cervicogenic HeadacheStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants were randomly allocated into two parallel groups with equal allocation (1:1 ratio). The control group received a standard physiotherapy program including heat therapy, TENS, ultrasound, and cervical mobility and strengthening exercises. The experimental group received the same physiotherapy program plus a 10-minute proprioceptive gaze direction recognition (GDR) training task during each session. Both groups underwent three sessions per week for eight weeks. The design allowed for comparison of outcomes between groups receiving standard therapy alone versus those receiving standard therapy combined with proprioceptive training.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hungarian University of Sports Science
- Sponsor type
- University, hospital or other
- Collaborators
- Cairo University
- Responsible party
- Principal investigator, Mohamed Abdelaziz Emam, Hungarian University of Sports Science
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07271004
- Sponsor's protocol ID
- P.T.REC/012/003409
- Acronym
- PTRHBCOP-CGH
- Status last verified
- Nov 2025
- First submitted
- 25 Nov 2025
- Last updated
- 8 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data (IPD) underlying the results reported in this study will be made available upon reasonable request. The shared dataset will include variables related to baseline demographics, group allocation, headache frequency, headache duration, and center-of-pressure (COP) path length outcomes. Data will be provided in a coded format without any information that could identify individual participants. Access will be granted to qualified researchers for academic and non-commercial purposes following approval of a methodologically sound proposal and signing of a data access agreement.
Publications
Nobusako S, Matsuo A, Morioka S. Effectiveness of the gaze direction recognition task for chronic neck pain and cervical range of motion: a randomized controlled pilot study. Rehabil Res Pract. 2012;2012:570387. doi: 10.1155/2012/570387. Epub 2012 May 7.
PubMed 22645685
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Proprioceptive Training Reduces Headache Burden and Center of Pressure Path Length in Patients With Cervicogenic Headache: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07271004
- Acronym / sponsor ID
- PTRHBCOP-CGH / P.T.REC/012/003409
- Conditions
- Cervicogenic Headache
- Keywords
- Cervicogenic Headache;, Headache Burden, Postural Balance, Proprioception, Eye Movements
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Hungarian University of Sports ScienceUniversity, hospital or other
- Collaborators
- Cairo University
- Study start
- 3 Jul 2024 (actual)
- Primary completion
- 15 Aug 2025 (actual)
- Study completion
- 20 Sep 2025 (actual)
- First posted
- 8 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Cervicogenic headache (CGH) is a secondary headache originating from dysfunction in the cervical spine and is associated with impaired sensorimotor control and postural instability. This randomized, assessor-blinded, parallel-group clinical trial aims to investigate whether adding gaze direction recognition (GDR)-based proprioceptive training to a conventional physiotherapy program can reduce headache burden and improve postural balance in individuals with CGH. Participants are randomly allocated to receive either standard physiotherapy or standard physiotherapy plus GDR training for eight weeks. Primary outcomes include headache frequency, headache duration, and center-of-pressure (COP) path length during quiet standing. The study is conducted in accordance with ethical guidelines and was approved by the relevant institutional review board.
Detailed description
Cervicogenic headache (CGH) is a secondary headache arising from disorders of the cervical spine and related structures. Individuals with CGH commonly present with impaired cervical proprioception and altered postural control. Sensorimotor retraining strategies, such as gaze direction recognition (GDR), have been used in chronic neck pain populations to target proprioceptive deficits; however, their application in CGH has not been comprehensively investigated.
This randomized, controlled, assessor-blinded clinical trial is designed to evaluate whether adding proprioceptive GDR training to a standardized physiotherapy program results in greater reductions in headache burden and improvements in postural balance compared with physiotherapy alone. Thirty-eight participants meeting ICHD-3 diagnostic criteria for CGH are randomly assigned in a 1:1 ratio to a control group receiving standard physiotherapy or to a treatment group receiving standard physiotherapy plus GDR training. The intervention is delivered three times per week for eight weeks.
The standardized physiotherapy program includes thermotherapy, transcutaneous electrical nerve stimulation (TENS), ultrasound therapy, and therapeutic exercises for cervical mobility, posture correction, and isometric strengthening. The treatment group receives the same program with the addition of a structured GDR proprioceptive task.
Gaze Direction Recognition Exercise (GDRE) Procedure:
During the GDRE, the therapist sits in a chair positioned 0.75 m behind the center of a wooden table (1.8 × 0.4 × 0.76 m). Six wooden blocks, numbered 1 to 6 from left to right, are placed along the table edge nearest the therapist, spaced 0.31 m apart. Patients sit in a chair behind the therapist with a clear view of the numbered blocks.
An assistant signals the start of each trial, at which point the therapist randomly directs his gaze and head toward one of the blocks. As patients observe the therapist's neck rotation from behind, they rotate their own head in the same direction and verbally report the number of the block they believe the therapist is looking at. Patients are instructed to avoid moving other body parts during head rotation. No accuracy feedback is provided to the patient. The assistant records both reaction time and accuracy for each response. Each GDRE session consists of 30 trials and lasts approximately 10 minutes.
Primary outcomes include headache frequency (attacks per month), headache duration (hours per attack), and center-of-pressure (COP) path length during quiet standing, measured at baseline and after eight weeks of intervention. The study protocol was reviewed and approved by the Faculty of Physical Therapy Ethics Committee, Cairo University, and all participants provide written informed consent before enrollment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants were randomly allocated into two parallel groups with equal allocation (1:1 ratio). The control group received a standard physiotherapy program including heat therapy, TENS, ultrasound, and cervical mobility and strengthening exercises. The experimental group received the same physiotherapy program plus a 10-minute proprioceptive gaze direction recognition (GDR) training task during each session. Both groups underwent three sessions per week for eight weeks. The design allowed for comparison of outcomes between groups receiving standard therapy alone versus those receiving standard therapy combined with proprioceptive training.
| Arm | Type | Receives |
|---|---|---|
| Proprioceptive | Experimental | Other: ProprioceptionParticipants in the experimental group received the same standard physiotherapy program as the control group, with the addition of a 10-minute proprioceptive Gaze Direction Recognition (GDR) training task during each session. The GDR training involved observing another person's head and neck rotations from behind and identifying the direction of gaze, requiring motor imagery and visuospatial judgment to activate cervical sensorimotor pathways. Task difficulty was progressively increased across sessions. Training was administered three times per week for eight weeks, each session lasting approximately 60 minutes. |
| Control Group | Active comparator | Other: Conventional physical therapyParticipants in the control group received a standardized physiotherapy program three times per week for eight weeks. Each 60-minute session included: 20 minutes of moist heat applied to the neck and shoulder region, 20 minutes of transcutaneous electrical nerve stimulation (TENS) at 50 Hz and 100 µs pulse width, 5 minutes of continuous-mode ultrasound therapy (1-1.5 W/cm²) to the cervical muscles, and A series of therapeutic exercises to improve cervical mobility, posture correction, and neck-muscle strength through isometric contractions. This program represented the conventional physiotherapy regimen for cervicogenic headache management. |
Who may qualify
- Ages
- 35 to 49 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Physician-diagnosed cervicogenic headache (CGH) according to current diagnostic criteria
- Age 35 to 49 years
- Unilateral pain originating in the neck and radiating to the frontotemporal region
- Pain aggravated by neck movements
- Restricted cervical range of motion
Key exclusion criteria (7 listed)
- History of head or neck injury or surgery
- Musculoskeletal disorders
- Neurological diseases or disorders
- Metabolic syndromes
- Hypertension or hypotension
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ProprioceptionThe GDR training involved observing another person's head and neck rotations from behind and identifying the direction of gaze, requiring motor imagery and visuospatial judgment to activate cervical sensorimotor pathways. Task difficulty was progressively increased across sessions. Training was administered three times per week for eight weeks, each session lasting approximately 60 minutes. Would you like me to now write the Intervention Description sections (the short entries that go under "Intervention Name," "Type," and "Description" linked to each arm)? Those are the next fields after the Arm descriptions. | Other | Proprioceptive |
| Conventional physical therapy20 minutes of moist heat applied to the neck and shoulder region, 20 minutes of transcutaneous electrical nerve stimulation (TENS) at 50 Hz and 100 µs pulse width, 5 minutes of continuous-mode ultrasound therapy (1-1.5 W/cm²) to the cervical muscles, and A series of therapeutic exercises to improve cervical mobility, posture correction, and neck-muscle strength through isometric contractions. | Other | Control Group |
Primary outcome
Headache frequency (attacks per month)
Time frame: Baseline and after 8 weeks of intervention
Change in the number of cervicogenic headache attacks per month, as recorded by participants in a headache diary. Headache frequency was averaged over four weeks at baseline and again at post-intervention. Lower values indicate improvement.
Headache duration (hours per attack)
Time frame: Baseline and after 8 weeks of intervention
Change in the mean duration of headache episodes, expressed in hours per attack, recorded from participant headache diaries. Duration was averaged across all episodes within each 4-week period at baseline and post-treatment.
1 secondary outcome
Center of Pressure (COP) path length (cm)
Time frame: Baseline and after 8 weeks of intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2025.
- Background: PubMed 22645685Nobusako S, Matsuo A, Morioka S. Effectiveness of the gaze direction recognition task for chronic neck pain and cervical range of motion: a randomized controlled pilot study. Rehabil Res Pract. 2012;2012:570387. doi: 10.1155/2012/570387. Epub 2012 May 7.
- Individual participant dataSharing planned: Yes. De-identified individual participant data (IPD) underlying the results reported in this study will be made available upon reasonable request. The shared dataset will include variables related to baseline demographics, group allocation, headache frequency, headache duration, and center-of-pressure (COP) path length outcomes. Data will be provided in a coded format without any information that could identify individual participants. Access will be granted to qualified researchers for academic and non-commercial purposes following approval of a methodologically sound proposal and signing of a data access agreement.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Proprioception and Conventional physical therapy in people with Cervicogenic Headache, run by Hungarian University of Sports Science at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Headache frequency (attacks per month) (time frame: Baseline and after 8 weeks of intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07271004, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2025.